Method for programming a patient care device

ABSTRACT

The present invention is directed to a system and method for providing care to a patient, comprising a patient care device having a number of configuration databases stored in a memory in the device. Each configuration database preferably includes protocols, operating limits, rule sets and/or operating features that collectively define an operating environment, or personality, of the device. Selection of a specific configuration database preferably is based at least in part upon patient-specific information obtained from any location in a distributed hospital network. Examples of such patient-specific information include patient age or size, patient medical characteristics, a location of the patient or a location of the care device. In a preferred embodiment, programming a patient care device to deliver a drug to a patient entails activating a configuration database and scanning a machine-readable drug label identifying a particular protocol stored in the activated database. The selected protocol includes default parameters for delivering the drug, and the label optionally includes instructions for deviating from the default protocol.

RELATED APPLICATIONS

This application is a divisional of application Ser. No. 09/793,475,filed on Feb. 26, 2001 and now issued as U.S. Pat. No. 7,384,410, whichis a continuation-in-part of application Ser. No. 09/379,212, filed onAug. 23, 1999 and now issued as U.S. Pat. No. 7,074,205, which is acontinuation of application Ser. No. 08/871,307, filed on Jun. 9, 1997and now issued as U.S. Pat. No. 5,941,846, which is acontinuation-in-part of application Ser. No. 08/403,503, filed on Mar.13, 1995 and now issued as U.S. Pat. No. 5,713,856. These relatedapplications are incorporated herein by reference in their entireties.

TECHNICAL FIELD

The present invention relates generally to a system and method formanaging patient care in a heath care facility, and in particular to asystem and method for integrating information from a distributed networkto alter the operating characteristics of a patient care device.

BACKGROUND OF THE INVENTION

Much attention in the health care industry has been placed on reducingthe incidence of medication dosing errors and improving overall qualityof patient care. Often medication dosing errors occur because a patientreceives the wrong medication, a wrong dosage of the correct medication,the correct dosage of the correct medication at the wrong time, or themedication has harmful interaction with other drugs. Recent advances inthe health care field have attempted to address these problems and toenhance efficiency and quality of patient care.

Many drugs are dispensed for patient use at or close to the point ofcare using programmable infusion pumps such as those disclosed by U.S.Pat. No. 5,713,856 to Eggers et al. and U.S. Pat. No. 5,041,086 toKoenig et al., both of which are incorporated herein by reference.Eggers et al. discloses a modular patient care system capable ofproviding therapy to a patient and monitoring patient condition. Thesystem of Eggers utilizes a central control module to control andmonitor a number of functional modules, including one or more infusionpumps and patient monitoring devices.

Most hospitals today have a pharmacy equipped with a computerized systemfor entering, preparing, and tracking prescriptions, managing druginventory, checking for drug incompatibilities, and printingprescription orders and labels. Typically, one or more medicationinfusions to be administered to a patient are prescribed by thepatient's physician. The pharmacy prepares the infusion solutionaccording to the physician's prescription and places the solution in anIV bag, syringe or other container. A printed label identifying thecontainer contents, the patient to whom the medication is prescribed,the prescribing physician, delivery instructions and/or otherinformation regarding the prescription. The label is generally typed orprinted in human readable characters. In some instances, bar codes areused to encode information on the label.

After a label is affixed, the container is transported to the patient'slocation and operatively attached to a bedside infusion pump system,such as that disclosed by Eggers et al. A nurse or other care providerthen programs the infusion system with drug delivery data from thelabel, typically by manually entering infusion parameters using akeyboard or a keypad. Alternatively, some systems seek to reduce dataentry errors by incorporating a bar code reader that scans coded datainto the pump system from the drug label or from a prescription order.The data may include, for example, rate of infusion, total volume to beinfused (VTBI) and, in multichannel or modular systems such as thatdescribed by Eggers et al., which channel or pump module is to be used.

U.S. Pat. No. 5,153,827 to Coutré et al. discloses a system forproviding an infusion apparatus with medication infusion parameters froma central pharmacy database. Infusion delivery parameters for aparticular treatment are printed from the central pharmacy database on amachine-readable labels, which are then carried to the patient locationand scanned into the bedside infusion apparatus. The system of Coutrérequires that all information used to program a pump is either scannedfrom a machine-readable label or entered manually by the user. Thus, theinfusion systems of Coutré do not utilize information from other sourceswithin the hospital or within the system itself.

U.S. Pat. No. 5,781,442 to Engleson et al. discloses a patient caremanagement system comprised of a network of computers having a varietyof input and output devices for receiving patient data and forgenerating or displaying reports. The disclosed system monitors ongoingadministrations of care to patients and automatically updates recordsand provides alarms when necessary. In an example of use, patient anddrug identification information are scanned into a bedside terminal andcommunicated to a central computer, where the data are processed. Thecentral computer then sends operating parameters to the terminal and theterminal programs an infusion pump in accordance with the operatingparameters.

In spite of recent advances in the art, there remains a need in the artfor a system that facilitates efficient and accurate programming of amedical treatment device while ensuring that the prescribed treatmentconforms with institutional and departmental guidelines with respect toa patient in a particular location and/or with particularcharacteristics.

SUMMARY OF THE INVENTION

The present invention generally involves the movement of patientinformation from a variety of sources such that the patient receives abetter quality of care, the care providers' assets are utilized moreefficiently and labor costs are reduced through the automation of someprocesses now done manually. The means of data transfer is typicallydone within a network, or network of networks, with some data enteringand exiting through portals which convert data formats. A preferredembodiment of the present invention is a modular patient care deviceconnected to a hospital network, wherein the capabilities and operatingcharacteristics of the device are altered as a function of its locationwithin the network.

According to the invention there is provided a patient care system,comprising a patient care device and means for transferringpatient-specific information to the device. The device includes a memoryfor storing a plurality of configuration databases, each of whichcomprises a plurality of distinct groups of device operating parameters.Transferring patient-specific information to the device enablesselection of a specific configuration database from the plurality ofconfiguration databases, based at least in part on the patient-specificinformation. The patient care system of the present invention alsopreferably includes a computer network and means for communicatingbetween the device and the network.

Still further according to the invention there is provided a method ofprogramming a patient care device to deliver a substance to a patient,comprising printing a coded label, said label including a protocolpointer identifying a first protocol for delivering the substance to thepatient; attaching the label to a container holding the substance;transporting the container to the patient care device; entering thepointer into the patient care system, the patient care system includingthe first protocol in a memory; and programming a functional unit of thepatient care system to deliver the substance to the patient inaccordance with the first protocol.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the nature and details of the invention,reference should be made to the following detailed description taken inconjunction with the accompanying drawings, in which:

FIG. 1 is a schematic diagram of a patient care management systemaccording to the present invention;

FIG. 2 is a schematic diagram of an interface unit according to thepresent invention;

FIG. 3 is a schematic diagram illustrating a configuration databaseaccording to the present invention;

FIG. 4 is a block diagram illustrating a number of different infusiontypes supported by the interface unit of the present invention;

FIG. 5 illustrates the process steps for programming an infusion systemto perform a particular infusion protocol in accordance with oneembodiment of the present invention;

FIG. 6 is a schematic diagram of an alternative embodiment of thepatient care management system of the present invention; and

FIG. 7 illustrates the process steps used to relate a programming modulewith a patient, in accordance with one embodiment of the presentinvention.

Like reference numerals refer to corresponding parts throughout theseveral views of the drawings.

DESCRIPTION OF THE INVENTION

FIG. 1 is a general illustration of a patient care system in accordancewith one embodiment of the present invention. In FIG. 1, a patient caredevice 12 is connected to a hospital network 10 including a pharmacymanagement system 34 and a hospital information system server 30. Eachelement 12, 30 and 34 is connected to network 10 by a transmissionchannel 32. Transmission channel 32 is any wired or wirelesstransmission channel, for example a 802.11 wireless local area network(LAN). In a preferred embodiment of the present invention, network 10also includes computer systems located in various departments throughouta hospital. For example, network 10 of FIG. 1 optionally includescomputer systems associated with an admissions department 36, a billingdepartment 38, a biomedical engineering department 40, a clinicallaboratory 42, a central supply department 44, one or more unit stationcomputers and/or a medical decision support system 48.

Patient care device 12 preferably comprises a system similar to thatdescribed in U.S. Pat. No. 5,713,856 to Eggers et al., which isincorporated herein by reference. Alternatively, other patient caredevices, such as pumps, physiological monitors (e.g., heart rate, bloodpressure, ECG, EEG, pulse oximeter, and other patient monitors), therapydevices, and other drug delivery devices may be utilized according tothe teachings set forth herein. Patient care device 12 preferablycomprises an advanced programming module 14, also referred to asinterface unit 14, connected to one or more functional modules 16, 18,20, 22. Interface unit 14 includes a central processing unit (CPU) 50connected to a memory, e.g. random access memory (RAM) 58, and one ormore interface devices such as user interface device 54, a coded datainput device 60, a network connection 52, and an auxiliary interface 62for communicating with additional modules or devices. Interface unit 14also preferably, although not necessarily, includes a main non-volatilestorage unit 56, preferably a hard disk drive, for storing software anddata and one or more internal buses 64 for interconnecting theaforementioned elements.

In a typical embodiment, user interface device 54 is a touch screen fordisplaying information to a user and allowing a user to inputinformation by touching defined areas of the screen. Alternatively, userinterface device 54 could include any means for displaying and inputtinginformation, such as a monitor, a printer, a keyboard, softkeys, amouse, a track ball and/or a light pen. Coded data input device 60 ispreferably a bar code reader capable of scanning and interpreting dataprinted in bar coded format. Alternatively, data input device 60 couldbe any device for entering coded data into a computer, such as devicesfor reading a magnetic strips, PCMCIA smart cards, radio frequencycards, memory sticks, CDs, DVDs, or any other analog or digital storagemedia. Other examples of data input device 60 include a voice activationor recognition device or a portable personal data assistant (PDA).Depending upon the types of interface devices used, user interfacedevice 54 and coded data input device 60 may be the same device.Alternatively, although data input device 60 is shown in FIG. 1 to bedisposed within interface unit 14, one skilled in the art will recognizethat data input device 60 may be integral within pharmacy system 34 orlocated externally and communicating with pharmacy system 34 through anRS-232 serial interface or any other appropriate communication means.Auxiliary interface 62 is preferably an RS-232 communications interface,however any other means for communicating with a peripheral device suchas a printer, patient monitor, infusion pump or other medical device maybe used without departing from the scope of the invention.

Network connection 52 is preferably a direct network connection such asa T1 connection, an integrated services digital network (ISDN)connection, a digital subscriber line (DSL) modem or a cable modem.Alternatively, any direct or indirect network connection may be used,including, but not limited to a telephone modem, an MIB system, an RS232interface, an auxiliary interface, an optical link, an infrared link, aradio frequency link, a microwave link or a WLANS connection.

Functional modules 16, 18, 20, 22 are any devices for providing care toa patient or for monitoring patient condition. In preferred embodimentof the present invention, at least one of functional modules 16, 18, 20,22 is an infusion pump module such as an intravenous infusion pump fordelivering medication or other fluid to a patient. For the purposes ofthis discussion, functional module 16 is an infusion pump module. Eachof functional modules 18, 20, 22 may be any patient treatment ormonitoring device including, but not limited to, an infusion pump, asyringe pump, a PCA pump, an epidural pump, an enteral pump, a bloodpressure monitor, a pulse oximeter, an EKG monitor, an EEG monitor, aheart rate monitor or an intracranial pressure monitor. Alternatively,functional module 18, 20 and/or 22 may be a printer, scanner or anyother peripheral input/output device.

Each functional module 16, 18, 20, 22 communicates directly orindirectly with interface unit 14, with interface unit 14 providingoverall monitoring and control of device 12. In a preferred embodiment,functional modules 16, 18, 20, 22 are connected physically andelectronically in serial fashion to one or both ends of interface unit14 as shown in FIG. 1 and as detailed in Eggers et al. However, oneskilled in the art will recognize that there are other means forconnecting functional modules with the interface unit may be utilizedwithout departing from the scope of the invention. It will also beappreciated that devices such as pumps or monitors that providesufficient programmability and connectivity may communicate directlywith the network without a separate interface unit. As described above,additional medical devices or peripheral devices may be connected topatient care device 12 through one or more auxiliary interfaces 62.

Each functional module 16, 18, 20, 22 typically includes module-specificcomponents 76, a microprocessor 70, a volatile memory 72 and anon-volatile memory 74 for storing information. It should be noted thatwhile four functional modules are shown in FIG. 1, any number of devicesmay be connected directly or indirectly to central computer 14. Thenumber and type of functional modules described herein are intended tobe illustrative, and in no way limit the scope of the present invention.Module-specific components 76 include any components necessary foroperation of a particular module, such as a pumping mechanism forinfusion pump module 16.

While each functional module is typically capable of a least some levelof independent operation, interface unit 14 monitors and controlsoverall operation of device 12. For example, as will be described inmore detail below, interface unit 14 provides programming instructionsto the functional modules 16, 18, 20, 22 and monitors the status of eachmodule.

In a preferred embodiment of the present invention, patient care device12 is capable of operating in several different modes, or personalities,with each personality defined by a configuration database. A particularconfiguration database is selected based, at least in part, bypatient-specific information such as patient location, age, physicalcharacteristics, or medical characteristics. Medical characteristicsinclude, but are not limited to, patient diagnosis, treatmentprescription, medical history, medical records, patient care provideridentification, physiological characteristics or psychologicalcharacteristics. As used herein, patient-specific information alsoincludes care provider information (e.g., physician identification) or apatient care device's 10 location in the hospital or hospital computernetwork. Patient care information may be entered through interfacedevice 52, 54, 60 or 62, and may originate from anywhere in network 10,e.g. from pharmacy 34, admissions 36, laboratory 42, etc.

Data to and from the various data sources can be converted intonetwork-compatible data with existing technology, and movement of theinformation between the medical device and network can be accomplishedby a variety of means. For example, patient care device 12 and network10 may communicate via automated interaction and/or manual interaction.Automated interaction may be continuous or intermittent and may occurthrough direct network connection 54 (as shown in FIG. 1), oralternatively through RS232 links, MIB systems, RF links such asBLUETOOTH (Amtel Corp., San Jose, Calif.), IR links, WLANS, digitalcable systems, telephone modems or other communication means. Manualinteraction between patient care device 12 and network 10 involvesphysically transferring, intermittently or periodically, data betweensystems using, for example, user interface device 54, coded data inputdevice 60, bar codes, computer disks, portable data assistants, memorycards, or any other media for storing data. Preferably, thecommunication means is bidirectional with access to data from as manypoints of the distributed data sources as possible. Decision-making canoccur at a variety of places within network 10. For example, and not byway of limitation, decisions can be made in HIS server 30, decisionsupport 48, hospital department or unit stations 46, or within patientcare device 12 itself.

Referring to FIG. 2, in a preferred embodiment of the present invention,interface unit 14 of patient care device includes a plurality ofconfiguration databases 200, 202, 204 and 206. The configurationdatabases are preferably stored in memory 56 of interface unit 14,however one or more databases may be stored within a functional module16, 18, 20, 22. One skilled in the art will understand that, whilememory 56 is preferably an internal hard disk, any permanent orremovable storage media including, but not limited to, CD-ROM, EEPROM,diskette, tape, external hard disk, memory card, flash memory, etc. maybe used. Optionally, portions of configuration databases 200, 202, 204,206 may be stored in volatile memory such as RAM 58.

Each configuration database 200, 202, 204, 206 preferably includes aunique database identifier, or pointer, 210, 212, 214, 216, foridentifying the respective database. Each database 200, 202, 204, 206includes a plurality of fields which define, for example, availabletreatment protocols, drug library information, module operating limits,rule sets, device features and possibly other information for defining aparticular operating parameters for patient care device 12. Eachconfiguration database 200, 202, 204, 206 defines a specific operatingenvironment, or personality, for patient care device 12. The individualconfiguration databases may be treatment location specific (e.g.intensive care unit [ICU], neonatal intensive care unit [NICU],pediatrics, oncology, etc.), disease state specific (intracranialpressure management, bone marrow transplant, etc.), user specific (LPN,RN, physician, etc.), or created by any other rationale. For example,according to one embodiment of the present invention, when patient caredevice 12 is located in the ICU it utilizes configuration database 200,and when device 12 is located the NICU it utilizes configurationdatabase 202. Each database 200 and 202, respectively, containsparticular operating parameters, treatment protocols, features etc. thatconfigure device 12 for use with patients in that unit of the hospital.

It should be noted that while FIG. 2 shows that each database includesthe same categories and types of information, the databases may varyconsiderably in terms of the types and amounts of information theycontain. Each of the various configuration databases, when selected, atleast in part defines the operating environment of device 12 andincludes a number of protocols or groups of default operatingparameters.

FIG. 3 is a more detailed representation of a sample configurationdatabase 204 according to the present invention. Configuration database204 includes a protocol module 230 comprising a plurality of protocols232, 234, 236, 238, 240. Each protocol includes a plurality of fields ofdefault operating parameters. In some cases an infusion protocol mayinclude a complete detailed infusion instruction with all of the defaultparameter values defined. Other infusion protocols may have partiallydefined parameters with additional data entry required by the user atthe point of care. For example, protocol A 232 of FIG. 3 includes fieldsof default operating parameter values and other data for controlling amedication infusion pump. The fields of this example include drug name300, concentration 304, container size(s) 308, nominal dose rate 312,initial bolus 316, maximum dose rate 320, minimum dose rate 324, maximumcumulative dose 328, drug incompatibility 332 and an ID field, recordpointer 336, for identifying or “calling” the protocol record. Eachfield typically includes stored default parameter values thatcollectively define a specific infusion protocol. Some fields, such asDrug Incompatibility 332, include a reference or link to anotherdatabase or drug library containing relevant information. Suchreferences to commonly used data libraries allow data to be sharedbetween protocols and/or configuration databases to avoid duplicatestorage and entry and to allow efficient updating of databaseinformation. Similarly, all protocols need not be stored within eachconfiguration database. Rather, protocols from different configurationdatabases may be saved in a master database or library, with eachindividual configuration database containing reference links toparticular protocols stored in the library. Such an arrangement isadvantageous because it avoids duplicate storage of identical protocolsand facilitates updating of library information.

When such a protocol is selected certain information must be provided.For example, device 12 may query the network to automatically obtaindata such as patient weight from the patient's electronic records inadmissions 36, critical dosage parameters from pharmacy system 34 anddouble check with laboratory 42 for recent test results which maycontraindicate the prescribed medication. A double check with pharmacysystem 34 of information coded on the drug prescription label also maybe automatically performed. Alternatively, the user may enter data suchas the patient weight and total dosage directly into the device andconfirms the automatically selected parameters. In one embodiment of theinvention, information in a drug specific protocol is a superset of theinformation in the “drug library”. Consequently, if the user selects adrug name, then certain parameters in the record are applied. Suchparameters would typically include the drug name, delivery rate limits,units of delivery, possibly concentration and container size. The userwould enter or scan in missing data such as patient weight, drug amount,diluent volume, dosage rate, total dosage and confirm the automaticallyselected parameters as prompted.

Different protocols typically include different fields and/or differentparameter values. Thus, Protocol B 234 might include additional fieldscompared to Protocol A 232, where the additional fields defineinstructions and/or parameters for implementing one or more differentinfusion types such as primary/secondary infusion, multichannelcoordinated infusion and multidose protocols (see FIG. 4).Alternatively, Protocol B 234 could include the same fields as ProtocolA 232, and differ only in terms of one or more parameter values in oneof the fields. For example, both protocols could be for infusion of thedrug dopamine, where one protocol has a concentration 304 value of 400mg/250 mL while the other has a concentration 304 value of 800 mg/mL.

Referring again to FIG. 3, the Rule Sets module 250 of database 204includes rules and/or algorithms that may be used to help defineparticular parameters within a database. For example, Rule Sets module250 could include an algorithm that modifies the maximum allowableinfusion rate or some other parameter based upon data obtained fromother sources in network 10, such as patient age, body weight or medicalhistory from Admissions 36 or test results from Laboratory 42. Otherrule sets in the Rule Sets module 250 may provide warnings orrecommendations upon the occurrence of particular events within pumpmodule 16, such as occlusion of the infusion line.

Still other rule sets within module 250 may contain algorithms thatutilize measurements from one or more functional modules to modifyoperation of another functional module. For example, module 250 maycontain a rule set that monitors blood pressure and intracranialpressure in a head trauma patient and calculates resulting perfusionpressure. The system then notifies the user when perfusion pressurefalls outside of a defined range and recommends adjusting infusion rateof a therapeutic agent to increase blood pressure or to decreaseintracranial pressure.

The Pump Limits module 260 of database 204 contains information thatdefines the overall operating limits of infusion pump module 16 andother pump devices, if any, attached to interface unit 14. The PumpLimits module 260 typically includes at least three fields, Air In Line(AIL) Limits 262, Max Rate 264, and Max Pressure 268. Because the PumpLimits module 260 of each configuration database 200, 202, 204, 206potentially contains different parameters and values, module 260 helpsdefine the operating characteristics or mode in which device 14 operateswhen a particular configuration database 200, 202, 204, 206 is active.

AIL Limits 262 defines an allowable limit for the amount of air in aninfusion line connected to a patient. Allowable AIL Limits may differfor particular patients or particular locations in the hospital. Forexample, an allowable limit of 50 μL may be set for pediatric patients,while a limit of 100-200 μL is used for general adult patients and 500μL for operating room and/or trauma patients.

Max Rate 264 defines the maximum allowable infusion rate for an infusionpump operating under that particular configuration database 20. Again,the defined Max Rate 264 values may differ among patient class,attributes, location, etc. For example, the maximum rate for deliveringheparin to pediatric patients may be set at 10 units/g/hr, while adultpatients have a limit of 500-1000 units/hr.

Feature Enable/Disable module 270 of configuration database 204 defineswhich particular infusion types, or features, are available to the userof system 14 when configuration database 204 is activated. In apreferred embodiment of the present invention, patient care system 14 iscapable of supporting a wide variety of such features, ranging fromsimple primary infusions used for hydration and keep-vein-open (KVO)applications to complex multichannel delivery applications. FIG. 4illustrates some of the various features or infusion types that aresupported by patient care system 14 according to one embodiment of thepresent invention. These features include, but are not limited to, DrugCalc 402, Primary/Secondary 404, Delayed Start (Del Start) 406, MultiDose 408, Total Parenteral Nutrition (TPN) 410, Multi Step 412, andMulti-Channel Coordinated Infusion (MCCI) 414. As mentioned previously,each of these features or infusion types may be implemented by aparticular protocol stored in protocols module 230. The foregoingfeatures are described briefly below; see U.S. Pat. No. 5,713,856 for amore detailed description of each.

Drug Calc 402 is a feature that allows calculation of drug infusionparameters such as rate or dose, based on patient weight, time units,and drug concentration. For example, the drug calculation function ofthe system allows the user to either: enter the desired drug dose andthe infusion pump functional unit microprocessor calculates the correctflow rate to achieve the desired dose; enter the desired flow rate andthe pump functional unit calculates the corresponding drug dose; orenter the desired bolus dose and the duration and the pump functionalunit calculates the bolus rate and the VTBI. The system may additionallyinclude a pediatric drug calculation function 424 which allows the userto enter, for example, flow rate, dose, and diluent volume. From theseuser entered parameters, the system calculates the amount of drug toadmix with the diluent to achieve a drug concentration consistent withthe selected dose and flow rate. Additional details regarding Drug Calc402 features are found in U.S. Pat. No. 5,713,856.

Typically, Drug Calc 402 mode is used to ensure accuracy of infusionrate data where a user enters at least a portion of the infusion programdata manually, e.g. through a touch screen or a keypad. For example,Drug Calc 402 may be used in conjunction with a drug-specific protocolsuch as stored in a configuration database. Alternatively, Drug Calc 402feature may be used in combination with a stored protocol that isidentified by a coded label to calculate missing parameter values or torecalculate new values (e.g. when a prescription includes a deviationfrom the standard protocol values).

Pri/Sec 404 feature allows use of protocols utilizing a primary infusionin conjunction with a secondary infusion solution. Historically aprimary infusion with an antibiotic secondary would be programmed byentering the primary and secondary rate and VTBI. In the presentinvention, a user can simply select the appropriate antibiotic regimenfrom the list infusion protocols and have the appropriate parametersautomatically retrieved. The user may then simply confirm the parametersand start the infusion.

Delay Start 406 delays the start of an infusion protocol or othertreatment for a particular duration of time or until a particular timeof day. Alternatively, start may be delayed until the happening of aparticular event. Such events include, but are not limited to, a signalfrom the interface unit in response to measured vital signs or otherphysiological parameters, completion of a stage of treatment by anothermodule, or a signal or data received by system 14 over network 10.

Multi Dose 408 allows multiple doses of a drug to be delivered overtime. A protocol incorporating the Multi Dose 408 feature typicallyincludes parameters for infusion rate, volume/dose, dose interval,number of doses and start time. As with all other protocols stored in aconfiguration database, a stored Multi Dose 408 protocol may be selectedor activated from the configuration database simply by scanning a codeddrug label containing the protocol identifier (with or withoutinstructions for deviating from the default protocol values). Anymissing or different values may then be entered by the user.

TPN 410 provides for total perenteral nutrition delivery using standardor custom ramp and taper protocols known to those skilled in the art.For example, a typical TPN protocol for delivering 2500 calories over aneight hour period utilizes an initial slow rate of delivery with agradual increase to a maintenance rate for a period of six to sevenhours, then a gradual decrease to complete the infusion.

Multi Step 412 is similar to TPN 410 in that it allows delivery of asubstance at various rates/volumes during a protocol. Standard 430defines standard multi-step protocols that are commonly used withoutdeviation for different patients. Custom 432 defines multi-step deliveryprotocols that are customized for particular situations. For example, acustom multi-step protocol may be used for delivery of dobutamine toincrease heart rate during a stress test. Such a protocol typicallyvaries the delivery profile of the drug to a patient over time, andpatient weight or age is used as a factor to select a particularprofile. Any number of custom multi-step protocols may be defined andused by one skilled in the art.

MCCI 414 may be used in conjunction with Multi Dose 408 and/or DelayStart 406 features to program complex coordinated infusion involvingdifferent solutions being infused from multiple modules, or channels.FIG. 5 illustrates a process flow for manually setting up a typicalmultichannel coordinated infusion according to the present invention.After the MCCI 414 function is selected in step 500 from a menu ofoperations displayed by the interface unit, the user is prompted toenter maintenance rate/volume 502. The user is then queried as towhether a flush 504 is desired. If yes, the user is prompted to enterflush volume and duration in step 506 before going to step 508. If noflush, or after flush volume and duration are entered, the user isprompted to choose continuous or between doses 508. The user is thenprompted to confirm the maintenance settings 510. The user then selectsa channel to use for the coordinated infusion in step 512. Step 514queries the user as to whether a multi-dose infusion is desired. Ifmulti-dose is to be used for that channel, the user enters themulti-dose parameters in step 516; if multi-dose is not to be used, theuser is prompted to enter delayed start time in step 518. If a dilution520 will be used, the user is prompted to enter dilution rate or volume522. After all parameters have been entered for that channel, the useris queried in step 524 as to whether additional infusions/channels areto be used. If so, steps 512-520 are repeated until all channels areconfigured. Once all channels are configured, the user is prompted tostart the MCCI 526.

According to a preferred embodiment of the present invention, some orall of the process steps shown in FIG. 5 and the values to be enteredmay be defined by a protocol stored in a configuration database. In sucha case, the steps of FIG. 5 may be replaced by simply scanning a codedlabel including the protocol identification, or alternatively byselecting the desired protocol from a menu, and verifying the parametervalues.

One skilled in the art will appreciate that the features and infusiontypes shown in FIG. 4 is intended to be illustrative of the presentinvention, and that patient care device 14 may support additional ordifferent features than those described herein.

In a preferred embodiment of the present invention, a plurality ofpatient care systems 12 are linked through a local area network (LAN) toa floor or unit server as shown in FIG. 6. For example, in a neonatalintensive care unit (NICU) having an NICU server 610, a plurality ofbedside patient care devices 650, 652, 654 and 656 are connected througha LAN 620 to unit server 610. Similar network servers may be providedthroughout the hospital, such as pediatrics 612, intensive care unit(ICU) 614, surgery (OR) 616 and oncology 618. Unit server 610 maycontain the configuration database information for that particular unit.The configuration databases in patient care device 12 could be updatedperiodically by downloading them from the unit server. Alternatively, aparticular configuration database could be downloaded from the server asit is selected for use in patient care system 650, 652, 654 or 656.Still another alternative is to have a unit- or department-specificconfiguration database that is automatically downloaded into a patientcare system 650, 652, 654, 656 when the system is operatively connectedto the department LAN. In any case, having some or all of theconfiguration database information stored in the unit server 610, 612,614, 616, 618 facilitates management and updating of the databases. U.S.Pat. No. 5,718,442 to Engleson et al., which is incorporated herein byreference, describes a system for connecting bedside medical devices toa hospital network, or network of networks, that may be suitable for usewith the present invention.

In yet another an alternative embodiment of the present invention,patient care device 12 is not directly connected to network 10. Rather,information is indirectly connected to network 10 using data inputdevice 60, user interface 54, auxiliary interface 62 or othercommunication means. Such communication means include, but are notlimited to, RS232 links, MIB systems, IR links, WLANS, portable dataassistants, memory cards, portable storage media or any other suitablecommunication means. Indirect communication can also be accomplished,for example, using modems with either the traditional phone system,voice over data or with cellular phones. In one example, a portablecomputer such as a personal data assistant may be used to transferdatabase information and/or infusion instructions from pharmacy system34 to patient care device 12. The various possible means of direct andindirect communication allow information to be continuously orperiodically transferred between the patient care device and othersystems in network 10 (e.g. pharmacy system 34, unit station server 46,laboratory 42, etc.).

Referring again to FIG. 1, regardless of how patient care device 12connects to or otherwise communicates with network 10, a feature of thepresent invention is that information is transferred, at leastoccasionally, between the various departments and systems within network10 such that functionality of patient care device 12 is altered byinformation received from the other systems. Such a distributed,coordinated care system provides for efficient utilization of assets andimproved quality of patient care by maximizing integration and utilityof information from various sources in the system and by limitingopportunities for human error. As discussed above, one example of howpatient care device 12 may alter its personality based upon informationreceived from other sources is selection of specific configurationdatabase defining a particular, treatment location-specific (e.g. NICU,Pediatrics, ICU, Surgery, Oncology, etc.), operating environment for thedevice 12. Similarly, prescription information, patient treatmenthistory, drug incompatibilies, etc. from Pharmacy 34 are utilized toprogram device 12 and minimize data entry errors.

Other communications between patient care device 12 and the variousdepartments or units 36, 38, 40, 42, 44, 46, 48 within network 10 serveto enhance overall quality of care. For example, communication with thebiomedical engineering department (Biomed 40) helps insure device 12safety and efficacy and optimize the efficient utilization of assets.Asset location can be accomplished by querying devices about theirserial number and location. As mentioned above, device 12 location canbe automatically determined by the device's connection to the network orsome other means of identifying itself and its location to the network.Preventative maintenance procedures and device diagnostics can beperformed remotely and blindly to the user. When problems occur,diagnostic analysis of perspective device behavior can be done remotely.This information can also be collected as a quality control device on anongoing basis. Device utilization data can be collected to optimize thedistribution of devices. As product updates or maintenance procedurescome due, notices could be posted on the devices's user interfaceindicating the pending need. Similarly utilization of resources may alsobe managed from Central Supply 44. They can benefit from the sameeffects as the biomed group. The location and use of medical devices canbe monitored and optimized based upon this data.

When a patient is first admitted in the Admissions department, a varietyof data relevant to the patient is entered into the hospital'sinformation system including patient sex, size, weight, medicalcondition, drug allergies, etc. This information can be used by themedical device 12 to advise the user of potential problems such asadverse drug reactions, incompatible dosing regimens and unlikely drugprescriptions. These could appear as prompts to the direct care giver oras flat-out restrictions for use beyond prescribed parameters. Inpatient monitoring applications it might include recommended alarmlimits, monitoring periodicity, etc.

A Billing department 38 may rely on information regarding utilization ofthe medical device, particularly the documentation of its use or thedelivery of specific medications, to effect the billing to the customer.The ability to track activities independent of their actual originoffers a way of cross checking them with the resultant improvement inefficiencies.

Networked computer terminals in Unit Stations 46, such as in a nurse'sstation in a particular hospital unit, allow care providers to assessremotely from any location connected into the distributed coordinatedcare network 10, the course of care and patient vital signs. Theparameters of care (flow rate, PCA parameters, dose, monitoringintervals, alarm limits, etc.) can be altered from any location in thenetwork, with the necessary authorization. The history of devicereadings, infusion site monitoring and back pressure readings, as wellas the infusion and revised parameters and monitoring limits, can bereviewed remotely.

By way of non-limiting example, the use of the patient care systemaccording to the present invention is explained in greater detail belowby reference to procedures for configuring patient care device 12 forproviding a prescribed treatment to a patient.

Most hospitals commonly have an established formulary of medicationswhich defines how the medications are typically dispensed. When apatient care management system according to the present invention isfirst installed, a hospital committee may be formed to determine howthat formulary would be applied to the patient care devices 12. Theconfiguration definitions (e.g., by hospital unit such as ICU, NICU,Pediatrics, Oncology, Surgery, etc.) are agreed upon and the drugs andtypical infusion protocols are established. In addition, all outerlimit, or guard rail, conditions are defined. This information isentered into a drug library editor and configuration management programsuch as INFUSION MANAGEMENT SYSTEM (Alaris Medical Systems, San Diego,Calif.).

When all of the definitions are complete, then a configuration can bereleased. Pumps at the institution are then updated by transferring theconfiguration databases into some or all of their pumps. Transfer of thedatabase information typically occurs over network transmission channel34. Alternatively, databases may be downloaded/updated using removablemedia, portable computers, personal data assistants, or any otherappropriate means for transferring information to patient care device12.

Assuring that the medication is being administered to the correctpatient is a key element of this system. Upon entering the hospitalevery patient is typically issued an identification number (patient ID)and an associated wrist band. Printed on the band or located within theband is the patient ID in text form and in coded form. Various optionsexist for the coded ID. For example, the band could utilize a bar code,a magnetic strip, or any other means of storing coded patientidentification information. The desired configuration database mightalso be recorded on the wrist band. For example, a child may have a bandwith an indicator that the pediatric configuration database is to beused.

The process steps involved in configuring a device to utilize aparticular configuration database according to one embodiment of thepresent invention are shown in FIG. 7. After power to device 12 isturned on 700 and an internal systems check 704 is performed, the devicedisplays on user interface 54 information pertaining to the currentpatient and/or the current location 708. In one embodiment of theinvention, this information is recalled from the last use of the device.Alternatively, the device location and or patient identification may bedetermined by information received through its connection to network 10and/or a LAN within the hospital. For example, referring to FIG. 5, adevice 650 connected over LAN 620 to a server in NICU 610 receivesinformation from the server that it should be located by Bed 1, and thata particular patient is scheduled to be in that bed. Accordingly, thedevice 650 utilizes that information as the default patient andlocation. Alternatively, device 650 automatically determines itslocation within the hospital by a sensor or other means of uniquelydetermining its location. A sensor is defined broadly herein as anydevice or process of sensing or detecting the location of a device,including, but not limited to, a network receptacle or port address, anetwork adapter, programmed location instructions, hospital recordsindicating location, an IR sensors or tags, RF sensors or tags, magneticsensors or tags, or any other means of detecting the location of adevice 650.

In step 712 the device queries the user whether the patient informationis correct. If the patient is new to the device, or if the informationis missing or incorrect, the user enters the patient ID in step 716.Patient ID is typically entered using input device 60, e.g., by scanninga patient's coded wristband including patient identificationinformation. Alternatively, patient ID may be entered manually using akeyboard, keypad, or other interface device 54. If the currentconfiguration database is missing or incorrect 720, the user is promptedto select the appropriate configuration database 724 (e.g. according tolocation, patient, physician, etc.). Alternatively, the appropriateconfiguration database ID may scanned into the system from the patient'sidentification band, or may be automatically retrieved from memory orfrom another location in network 10 once the patient identity, locationor other patient-specific information is entered into device 12.

When a physician orders an IV, the order is typically first sent to thepharmacy (where it is entered into the hospital's pharmacy system 34).Most hospitals include a pharmacy computer system capable of maintainingrecords of medications already given as well as those prescribed in thefuture. Most commercially available pharmacy systems allow for adversedrug interactions to be checked for as part of the process prescriptionentering/drug dispensing process.

According to a preferred embodiment of the present invention, after theorder is entered the prescription is prepared. If the drug is compoundedor sourced in the pharmacy, then the prescribed medication is preparedand placed in a container. Pharmacy system 34 would then translate theinfusion order from the hospital pharmacy software onto a label withencoded message and accompanying text. The label preferably includes atleast the following information: patient ID, infusion protocolreference, infusion protocol deviations, or deltas, if any, andscheduled time of infusion. The label is affixed to the medicationcontainer before the prescription is transported to the unit nursingstation. Medications are preferably transported from the Pharmacy to thenurse's station by hospital personnel or contained within drugdispensing cabinets near the nurse's station. Alternatively, drugs maybe transported using a robotic system, such as a PYXIS system (PyxisCorporation, San Diego, Calif.). If the drug is to be distributed from aunit nursing station, then the same tape of label may be printed at thestation and affixed to the drug container.

At an appropriate time, the labeled medication container is then takento the patient's location. The bar code reader (or other data inputdevice) is used to scan the coded drug label, the patient's coded IDband and the caregiver's ID badge, and optionally supplementaryprescription information or medical device configuration instructions(including configuration database ID) printed on the label or anaccompanying order. The scanned information is stored in memory 58,while device 12 first compares the scanned data to ensure that thepatient identity corresponds to the patient information on themedication label, and that the prescription is being administered at theappropriate time. After the correct patient, prescription and time areverified, device 12 recalls from the active configuration database theprotocol or other program information identified on the container label.The default parameter values are adjusted by any delta informationincluded in the prescription. The user is prompted to enter, using atouch pad, bar code reader, or any other appropriate means, any missingor incomplete data. Optionally, some data may be obtained automaticallyfrom network 10 or from the appropriate department server based upon theentered patient ID, caregiver ID, user commands, etc. Once all requiredsettings have been entered, central unit 14 displays the values, eitherserially or in one or more groups, to the user for verification. Onceall information is entered and verified, interface unit programs thefunctional module(s) to perform the prescribed treatment.

It should be noted that the prescription label or other treatmentinstructions may identify multiple protocols and other instructions. Themultiple protocols (or a single complex protocol), may define aplurality of operations to be performed by device 12. For example, theprescription label or prescription order could identify a multichannelcoordinated infusion protocol involving multiple channels and infusionsolutions. Additionally, the same order may identify a protocol for (ordetail instructions for) programming a functional module or auxiliarydevice to monitor the patient physiological parameters, such as a bloodpressure, heart rate, O2 saturation, respiratory rate, etc. Interfaceunit 14 monitors the measured parameters and, depending upon active rulesets and other configuration instructions, can modify infusionparameters based upon signals received from the physiological monitors.Such feedback systems may be useful for titration of drugs, to controlanesthesia, or to regulate blood pressure.

Various embodiments of the invention have been described. Thedescriptions are intended to be illustrative, not limitative. Thus, itwill be apparent to those skilled in the art that modifications may bemade to the invention as described without departing from the scope ofthe claims set out below.

What is claimed is:
 1. A method of programming a patient care device to deliver a substance to a patient, comprising: printing a coded label, said label including a substance delivery protocol identifier; attaching the label to a container holding the substance; transporting the container to the patient care device; entering the protocol identifier into the patient care device; selecting a configuration database from a plurality of configuration databases stored in a memory in the patient care device, wherein the selection depends on one of a location of the patient, a disease state of the patient or an identity of a user of the patient care device; retrieving from the selected configuration database stored in the memory in the patient care device a specific protocol identified by the protocol identifier, said specific protocol comprising a plurality of delivery parameters and default values; programming the patient care device to deliver the substance to the patient in accordance with the specific protocol.
 2. The method of claim 1, wherein the selected configuration database further includes additional information defining an operating environment for the device, said information comprising any of a protocol, a rule set, a device operating limit or a device operating feature.
 3. The method of claim 1 wherein selecting the configuration database comprises transferring patient-specific information to said patient care device to enable selection of the configuration database from said plurality of configuration databases based at least in part on said patient-specific information.
 4. The method of claim 3, wherein transferring of said patient-specific information comprises entering the patient-specific information into the patient care device using a coded data input device or a network connection.
 5. The method of claim 4, wherein said entering step comprises scanning the coded label with a coded data input device operatively connected to said patient care system.
 6. The method of claim 5, wherein the data input device is a bar code reader.
 7. The method of claim 1, wherein the coded label further includes a value representing a deviation from the specific protocol, such that the programming step includes programming the patient care device to deliver the substance to the patient in accordance with the deviation from the specific protocol.
 8. The method of claim 1, wherein the coded label further includes supplementary information, said information including a patient identifier, a deviation from the first protocol and a scheduled time to begin delivery of the substance to the patient.
 9. The method of claim 8, further comprising: scanning a patient identification code attached to the patient; confirming that the patient identifier on the container label corresponds to the patient identification code; and entering the supplementary information from said coded label, wherein the step of programming the patient care device comprises programming the patient care device to deliver the substance to the patient in accordance with the deviation from the specific protocol at the scheduled delivery time.
 10. The method of claim 9, further comprising scanning a provider identification code. 